Enforcement Report - Week of January 2, 2013

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Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.

It has been determined that, in some cases,
pulley drive components have broken parts or have become loose, mispositioned, or
disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or
may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the
reaction vessel.

Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).

The Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period).

Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.

Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.